Dr. Barbara Berglund

Barb Berglund has been working in the pharmaceutical industry for over twenty years. She has worked directly with liquid and lyophilized sterile parenterals, solid dosages, suspensions, microencapsulated products, intravitreal injection, and nasal presentations for approval in the US, Canada, Europe, Britain, Brazil and Japan. Her experience spans quality and operations, including strategic leadership roles in quality control, quality assurance, project management, and clinical trial manufacturing.

Each year, she teaches a Validation of Lyophilization course at the Parenteral Drug Association (PDA). She provides general GMP and GDP training. She has presented lean project management and QC transfer topics at the PDA annual meeting, and project management topics at the Project Management Institute Community of Practice annual meeting. She has provided numerous web-based topical discussions which address QC regulatory and compliance issues.

In her quality roles, Barb has managed QC groups responsible for analytical procedure development, transfer, and validation activities. She has led QA teams responsible for oversight of development and technical transfer of new generic products and processes from inception into full scale manufacturing, including procedure development and validation, knowledge management, and process development and validation. She has created and implemented a program for analytical procedure transfer based on ICH guidelines and a knowledge management program in support of Quality by Design. She has remediated troubled CAPA, Complaint and Supplier Quality programs to free organizations from warning letters. Barb has also managed various initiatives to certify companies to ISO 9001 and ISO 13485, and accreditation to ISO 17025 standards.

While in operations roles, Barb has worked directly with innovator formulations, generic applications, orphan indications, and changes in dosage presentation. This work includes products at proof of concept, all phases of clinical trial, process validation, and commercialization. The products range from diluents to small molecules, peptides, proteins, encapsulated DNA and adjuvated vaccines. Barb has worked with solid and liquid active and excipient ingredients, purified drug substances and formulated drug products.

Barb has an undergraduate degree in Chemistry and post graduate degrees in Chemistry and in Pharmacological & Physiological Science. She received her Project Management Professional certification in 2007, her Six Sigma Green Belt in 2008, and her Certified Manager of Quality/Operational Excellence and Certified Quality Auditor from the American Society for Quality in 2015.

Education

Ph.D, Saint Louis University, Department of Pharmacological and Physiological Science
M.S., UM-St Louis, Department of Chemistry
B.A., UM-St Louis, Department of Chemistry
Emerging Leaders Program, Gonzaga University

Memberships and Certifications

10/07 – present PMP, Project Management Professional
03/15 – present CQM, ASQ Certified Quality Manager / Organizational Excellence
12/15 – present CQA, ASQ Certified Quality Auditor
11/08 – present Green Belt, Lean Manufacturing
08/07 – present PMI, Project Management Institute
06/04 – present PDA, Parenteral Drug Association
01/13 – present ASQ, American Society for Quality

 

 

Special accomplishments

Built and integrated QC and QA systems in support of a startup pharma manufacturing facility.

Brought multiple labs completely into ISO 17025 accreditation.

15 years experience in quality and operations in liquid and lyophilized sterile parenteral (aseptic) pharmaceutical and device manufacturing facilities.

Designed the infrastructure for an all-new department within QC and microbiological QC. This included job descriptions, hours required to meet the projected needs of the business, number of employees needed (including additional supervision) and core reporting relationships.

Designed and implemented a tiered promotion system for the QC lab. This included job description development, title development, and structural department changes.

Designed and implemented an all-new training program for the QC lab. This included a paradigm shift from linear “read and understood” training to a practical, modular approach. This included core curriculum as well as job specific training tasks.

Designed, developed, and implemented training programs for cGMP, project management, basic lyophilization training, and QC compliance. These include lecture, workshop, and web-based training.

Designed and implemented a streamlined and generic batch record for the CTM manufacturing facility. This allowed for ease of technical transfers, increased consistency batch-to-batch and a dramatic decrease in deviations.

Designed and implemented an all-new training program for the CTM manufacturing facility. This included a requirement to walk through a process in advance of finalizing manufacturing documents and hands-on training in advance of task performance.

Presented at PDA, PMI, ComplianceOnline, and other in-person and web-based conferences.

Training programs

Berglund BA (2008). Lyophilization Training. HS offsite training course, 7/08, Spokane.

Berglund BA (2009). Lyophilization Training for QC. HS training course, 1/09, Spokane.

Berglund BA (2010). Project Management of Lean or Fast-Turnaround Projects.  Workshop presented in June, July, and August, 2010 at HS.

Berglund BA (2010). Analytical Method Transfer Strategies for a Contract Manufacturing Organization. Webinar presentation for the PDA June
22, 2010.

Berglund BA and Allen W (2010). Initiation of Short-Term and Process Improvement Projects. Webinar presented for PMI 8/28/10 and 8/29/10.

Berglund BA (2010). Planning Phase of Short-Term and Process Improvement Projects. Webinar presented for PMI 12/13/10.

Berglund BA (2011). Does Your Pharmaceutical Lab Have GMP and non-GMP Functions? Web training presented via ComplianceOnline 1/19/11, repeated on 9/9/11, 2/10/12, 7/13, 6/14, 5/16 and 5/17.

Berglund BA (2011). How to Transfer QC Procedures for Commercial Products in Pharma Industry – ICH and USP Guidelines. Web training presented via ComplianceOnline 2/03/11, repeated on 9/29/11,  7/13, 7/15 and 4/17.

Berglund BA (2011). Designing appropriate product specifications for lyophilized parenteral products. Web training presented via ComplianceOnline 4/21/11, repeated 10/20/11.

Berglund BA and Bossert KA (2011). Validation of Lyophilization. 2-day training course presented on 6/23/11 – 6/24/11 via the PDA TRI Courseprogram, Bethesda, MD; repeated 3/12; 10/13; 12/14; 5/15; 12/16; 5/17.

Berglund BA (2011). Scientifically Sound Approach to Transfer of Analytical Procedures. Part of a 2-day course offered via IPA Canada, 10/4/11 –10/5/11.

Berglund BA (2011). Approaching unknown cause laboratory investigations for pharmaceutical tools using lean tools. Web training via
ComplianceOnline 10/06/11; repeated 6/12; 6/13.

Oral and Poster Presentations

Howlett AC, Berglund B, Cantrell C, Evans D, Wilken G, Pinto J, Boring D, and Rice K (1994). The pharmacology of endogenous compounds that interact with the cannabinoid receptor in the brain. International Cannabinoid Research Society, 7/94, Montreal.

Tong W, Collantes ER, Welsh W, Howlett AC, Berglund BA (1996). A low energy arachidonlyethanolamide conformer that exhibits pharmacophoric similarities to 9-nor-9-hydroxy hexahydrocannabinol. International Cannabinoid Research Society, 6/96, Cape Cod.

Howlett AC, Song C, Wilken GH, Pigg JJ, Berglund BA (1996). Characterization of the rat brain cannabinoid receptor using receptor peptide fragments and site-directed antibodies. International Cannabinoid Research Society, 6/96, Cape Cod.

Berglund BA, Boring DL, Howlett AC (1996). Cerebrodiene, arachidonyl ethanolamide and hybrid structures: potential for interaction with brain cannabinoid receptors. Frontiers in Bioactive Lipids, 5/96, Washington DC.

Fleming P, Berglund B, Howlett AC, Rice KC (1997). Synthesis and biological evaluation of anandamide analogs. CPDD, 4/97.

Berglund B, Fleming P, Rice K, Boring D, Howlett A (1997). Investigation of structural analogs of arachidonylethanolamide for binding and activation of cannabinoid receptors. International Cannabinoid Research Society, 6/97, Atlanta.

Berglund B, Cartier E, Fleming P, Rice K, Boring D, Howlett A (1997). Investigation of structural analogs of anandamide for binding and activation of peripheral cannabinoid receptors. Eicosanoids and other Bioactive Lipids in Cancer, Inflammation and Related Disease, 9/97, LaJolla.

Berglund BA, Fleming PR, Rice KR, Howlett AC (1998). Characterization of structural requirements of ligand binding to the CB1 and CB2 cannabinoid receptors. IUPhAR, 7/98, Munich.

Shim J-Y, Welsh WJ, Berglund BA, Howlett AC, Fleming PF, Rice K (1999).  Prediction of the bioactive conformation of arachidonyl ethanolamide using the distance constrained systematic search. ACS, 4/99.

Berglund BA (2008). Validation Requirements for Lyophilized Products in a Parenteral Manufacturing Facility: Focus on Aseptic Processing, Clinical Trial, and Commercial Scale Lyophilization. PharmaED’s Lyophilization, 9/08, Philadelphia.

Berglund BA (2010). Analytical Method Transfer Strategies for a Contract Manufacturing Organization. Podium presentation for the PDA 2010 Annual Meeting, 3/15/2010.

Berglund BA (2010). Knowledge Management: Application of Project Management and Program Management Best Practices to Lean Manufacturing and Lean Laboratory Projects. Podium presentation for the PDA 2010 Annual Meeting, 3/16/2010.

Berglund BA (2011). Increasing Success of Lean and Short-Term Projects Using the Initiation Phase. Podium presentation at the PMI Pharmaceutical Community of Practice, Durham, NC, 3/08/11.

Berglund BA & Allen WF (2011). The Application of PMBOK Guide Practices at Your Pharmaceutical Manufacturing Organization. Podium presentation at the PMI North America Congress, Dallas, TX, 10/23/11.

Publications

Metheny N, Reed L, Berglund B, Wehrle MA (1994). Visual characterization of aspirates from feeding tubes as a method for predicting tube location. Nursing Res. 43:282-287.

Howlett AC, Berglund BA, Melvin LS (1995). Cannabinoid receptor agonists and antagonists. Current Pharm. Des. 1,343-54.

Boring DL, Berglund BA, Howlett AC (1996). Cerebrodiene, arachidonyl-ethanolamide, and hybrid structures: potential for interaction with brain cannabinoid receptors. Prostaglandins Leukot Essent Fatty Acids. 55(3):207-10.

Tong W, Collantes ER, Welsh WJ, Berglund B, Howlett AC (1998). Derivation of a pharmacophore model for anandamide using constrained conformational searching and comparative molecular field analysis. J Med Chem. 41(22):4207-15.

Howlett AC, Song C, Berglund BA, Wilken GH, Pigg JJ (1998). Characterization of CB1 cannabinoid receptors using receptor peptide fragments and site-directed antibodies. Mol. Pharmacol. 53(3):504-10.

Berglund BA, Boring DL, Wilken GH, Makriyannis A, Howlett AC, Lin S (1998). Structural requirements for arachidonylethanolamide interaction with CB1 and CB2 cannabinoid receptors: pharmacology of the carbonyl and ethanolamide groups. Prostaglandins Leukot Essent Fatty Acids. 59(2):111-8.

Berglund BA, Boring DL, Howlett AC (1999). Investigation of structural analogs of prostaglandin amides for binding to and activation of CB1 and CB2 cannabinoid receptors in rat brain and human tonsils. Adv Exp Med Biol. 469:527-33.

Berglund BA, Fleming PR, Rice KC, Shim J-Y, Welsh WJ, Howlett AC (2000). Development of a novel class of monocyclic and bicyclic alkyl amides that exhibit CB1 and CB2 cannabinoid receptor affinity and receptor activation. Drug Des. Discov. 16(4): 281-94.